Suturing Through-the-scope System Used for Prophylactic Closure of Colonic Post-ESD Defects (STITCH)

Istituto Clinico Humanitas

Status: Not yet enrolling

Conditions: Precancerous Lesion of Colon

Treatments: Device: TTS suturing system

Study type: Interventional

Funder types: Other

Identifiers

NCT06443047

3938 - STITCH

Details and patient eligibility

About

The goal of this study is to perform a randomized trial to compare a new through-the-scope suturing system and conventional clips for closure of defect after ESD for 30-60 mm colonic polyps. More precisely, the hypothesis posits that the new through-the-scope suturing system can achieve higher complete closure rates in a shorter time in comparison to conventional clips.

Full description

Large superficial colonic polyps are increasingly detected thanks to colorectal cancer screening programs worldwide. ESD is the technique which provides a high-quality resection of these large polyps.

Nevertheless, several adverse events affect ESD, especially in the colon. They could be life-threatening, call for or prolong the hospitalization, require blood transfusion, additional endoscopic or surgical procedures and increase costs.

Thus, preventing these adverse events is an important clinical and medico-economic objective. Endoscopic closure of post-ESD defects could reduce this risk. However, closing these large defects with conventional clips can be difficult, unsuccessful and prolong the duration of the whole procedure. A new trough-the-scope suturing system could successfully provide a complete endoscopic closure of post-ESD defects in the colon in a reasonable time.

Expected benefits are a decrease of morbidity and costs related to colonic ESD procedure

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient suffering from 30-60 mm colonic polyps with indication of ESD
• Male or female patients aged > 18 years' old
• Patients able to fill in questionnaires written in Italian

Exclusion criteria

• Failure of endoscopic resection
• Suspicion of deep submucosal cancer by analysis of pit pattern (KUDO Vn)
• Polyp involving the appendix deeply (type 2 or 3 according to Toyonaga classification)
• Polyp inside the ileo-cecal valvula.
• Rectal lesions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

ESD with clips

No Intervention group

Description:

Closure of the defect will be performed at the end of the Endoscopic Submucosal Dissection procedure with clips (Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure.

TTS suturing system

Experimental group

Description:

Closure of the defect will be performed at the end of the ESD procedure with a new TTS suturing system (X-Tack Boston scientific®). Pictures or movies of the closing defect will be necessary to independently confirm the complete closure.

Treatment:

Device: TTS suturing system